| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Open angle glaucoma (OAG) or ocular hypertension (OHT) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Open angle glaucoma (OAG) or ocular hypertension (OHT) |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To evaluate:
The ocular hypotensive efficacy of PG324 Ophthalmic Solution relative to GANFORT® Ophthalmic
Solution at 08,00,10:00 and 16:00 hours at Week 2, Week 6 and Month 3. |
|
| E.2.2 | Secondary objectives of the trial |
To evaluate:
• The ocular and systemic safety of PG324 Ophthalmic Solution relative to GANFORT® Ophthalmic solution over a 6-month period.
• Change in Self-Administered National Eye Institute ( NEI) Visual Functioning Questionnaire 25 (VFQ 25) score from baseline to study exit for PG324 compared to GANFORT®.
• Change in self-administered Short Form Health Survey Questionnaire 36 (SF-36 v2) score from baseline to study exit for PG324 compared to GANFORT®. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Subjects have to meet all of the following criteria at screening and qualification visits to enter into the study:
1. Must be 18 years of age or older
2. Diagnosis of OAG or OHT in both eyes (OAG in one eye and OHT in the fellow eye is acceptable)
3. Subjects insufficiently controlled and/or subjects considered in need for combination therapy by the investigators
4. Medicated intraocular pressure ≥ 17mmHg in at least one eye and < 28mmHg in both eyes at the screening
visit.
5. Unmedicated (post-washout) IOP > 20mmHg in at least one eye and < 36mmHg in both eyes at 2
qualification visits at 08:00 hour, 2-7 days apart. At the second qualification visit, have IOP > 17mmHg in
at least one eye and < 36mmHg in both eyes at 10:00 and 16:00 hours. Note: For purposes of determining
eligibility of subjects to be enrolled the non–integral IOP mean number will be used. Any non-integral
mean IOP number should not be rounded. If only one eye qualifies at the second qualification visit it
MUST be the same eye that qualified on the first visit and this will be the study eye for the duration
of the study.
6. Best corrected visual acuity +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200 or better Snellen visual acuity in each eye)
7. Be able and willing to give signed informed consent and follow study instructions
8. Women must be either of non-child bearing potential, or women with child bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
9. Women of child bearing potential must have a negative urine pregnancy test within 7 days of first dose of study treatment and agree to use highly effective contraception during the study and for 3 months after the last dose of study medication
10. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective form of contraception from time of randomization and for 3months following the last dose of study medication.
11. In France, a subject will be eligible for inclusion in this study only if either affiliated to or as a beneficiary of a social security number |
|
| E.4 | Principal exclusion criteria |
Subjects meeting any of the following criteria during screening or qualification evaluations (e.g., at the time of randomization) will be excluded from entry into the study:
Ophthalmic:
1. Clinically significant ocular disease (e.g. corneal edema, uveitis, or severe keratoconjunctivitis sicca)
which might interfere with interpretation of the study efficacy endpoints or with safety assessments,
including subjects with glaucomatous damage so severe that washout of ocular hypotensive medications for 4 weeks or longer if needed is not judged safe as it would put the subject at risk for further vision loss.
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles (i.e., Grade 2 Shaffer (Chan Ry 1981) or less; extreme narrow angle with complete or partial closure). Note: Previous laser peripheral iridotomy is NOT acceptable
3.Intraocular pressure ≥ 36mmHg (unmedicated) in either eye (individuals who are excluded for this criterion are not allowed to attempt requalification), or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combination medications, for the purpose of this exclusion criterion, count as one medication. However, subjects currently taking 2 fixed dose combination products are excluded.
4. Treatment-naïve subjects
5. Prior treatment with GANFORT® topical eye drops where the subjects IOP did not achieve the target IOP
and was considered either a therapeutic failure or to have insufficient response. Subjects currently
(immediately prior to screening visit) being treated with GANFORT® are excluded from the study.
6. Known hypersensitivity to any component of the investigational formulations to be used (e.g., benzalkonium chloride etc.) or to fluorescein
7. Previous glaucoma intraocular surgery, including SLT or ALT in either eye.
8. Refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, corneal cross-linking, keratoplasty)
9. Ocular trauma within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening
10. Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, keratitis, current evidence or history of herpes simplex or zoster keratitis in either eye at screening.
11. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study, with the exception of a) ocular hypotensive medications which must have been the same medication for 30 days prior to screening (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after, screening), c) lubricating drops for dry eye (which may be used throughout the study) as prescribed by the Investigator.
12. Mean central corneal thickness greater than 620μm at screening
13. Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g., keratoconus)
Systemic:
14. Clinically significant abnormalities in laboratory tests at screening
15. Known hypersensitivity or contraindication to GANFORT® (Appendix 3 Marketed Product Medication
Information Section 4.3) and to β-adrenoceptor antagonists (e.g. Chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third-degree heart block or congestive heart failure; cardiac failure, cardiac shock and severe diabetes).
16. Clinically significant systemic disease which might interfere with the study
17. Participation in any investigational study within 30 days prior to screening
18. Systemic medication including corticosteroid containing drugs that could have a substantial effect on IOP
which HAVE NOT been maintained at a consistent dose and regime within 30 days prior to screening and
are anticipated to change in dose and/or regimen during the study.
19. Use of topical steroid containing medications on the face or in or around the eyes will exclude the subject
(see section 5.6 concomitant medications).
20. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a
medically acceptable and highly effective form of birth control. An adult woman is considered to be of
childbearing potential unless she is one year post-menopausal (1 year without menses with appropriate
clinical profile, e.g. age appropriate, > 45 years in the absence of HRT. In questionable cases the subject
must have FSH value > 40mIU/mL and an estradiol value < 40pg/mL (< 140pmol/L)) or three months
post-surgical sterilization.
21. Vulnerable subjects such as minors, adults under legal protection or unable to express their consent (e.g. hospitalized persons in coma), persons deprived of liberty (prisoners from jails), or persons subject to psychiatric care. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary efficacy outcome will be comparison of PG324 Ophthalmic Solution relative to GANFORT® for:
• Mean IOP within a treatment group at the following time points: 08:00, 10:00, and 16:00 hours at the Week 2, Week 6, and Month 3 study visits. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Primary efficacy endpoint of mean IOP to be evaluated at 08:00, 10:00 and 16:00 hours at the Week 2, Week 6 and Month 3 study visits. |
|
| E.5.2 | Secondary end point(s) |
Secondary efficacy outcomes will be comparison of PG324 Ophthalmic Solution relative to GANFORT® for:
• Mean diurnal IOP within a treatment group at each post-treatment visit.
• Mean change from diurnally adjusted baseline IOP at each post-treatment time point.
• Mean change from baseline in diurnal IOP at each post-treatment visit.
• Mean percent change from diurnally adjusted baseline IOP at each post-treatment time point.
• Mean percent change from baseline in diurnal IOP at each post-treatment visit.
• Percentages of subjects achieving pre-specified mean, mean change, and percent mean
change in diurnal IOP levels. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| End of last dose treatment and at the end of clinical trial. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Yes |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 60 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The end of the study will be defined as the point when the last subject has completed the last study visit 9 (180 days). |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | 12 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 12 |
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